drugset / Trial / NCT01839279

A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial

NCT01839279

Phase 2 Completed 136 enrolled Acorda Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ECG effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol.

Timeline

Start
2013-04
Primary completion
2014-02
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Moxifloxacin Small molecule 400 mg
Subject Tizanidine Small molecule 2 mg Oral
Subject Tizanidine Small molecule 4 mg Oral

Indications

No indication recorded.